Fecal Microbiota Transplant for Inflammatory Bowel Disease
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Clinical improvement of IBD
研究概览
简要总结
Currently enrolling only patients with Ulcerative Colitis. Enrollment and experimental treatment of patients with Crohn's Disease stopped for a safety evaluation.
This is a prospective, open label pilot study in which patients with symptoms of Inflammatory bowel disease will receive FMT therapy delivered via colonoscopy.
The investigators hypothesize that FMT is a safe and effective treatment for patients with inflammatory bowel disease. The aims are:
- To determine if symptoms of inflammatory bowel disease can be successfully treated by Fecal Microbial Transplantation.
- To determine if endoscopic appearance of colon or ileum improves following treatment by Fecal Microbial Transplantation.
详细描述
Currently enrolling only patients with Ulcerative Colitis. Enrollment and experimental treatment of patients with Crohn's Disease stopped for a safety evaluation.
This is a prospective, open label pilot study in which patients with symptoms of acute or chronic inflammatory bowel disease will receive FMT therapy delivered via colonoscopy.
Number of Subjects:
This study will aim to enroll approximately 60 patients with inflammatory bowel disease.
All patients who have IBD will be evaluated at the UCSF Center for Inflammatory Bowel Disease. Patients who are eligible for the study will be identified during these regularly scheduled clinic visits. Patients who express interest will be set up for a meeting with a clinical research coordinator who will go over the study in detail and will obtain informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with history of Ulcerative Colitis confirmed by endoscopy and pathology and with a Mayo clinic ulcerative colitits disease activity score of 6 or greater.
- •Concurrent therapies with mesalamine, immunomodulators, corticosteroids and biologic agents will be allowed to continue during study.
排除标准
- •Female patients who are pregnant.
- •Patients with severe immunosuppression (absolute neutrophil count < 1000 or CD4 count <200).
- •Patients with untreated enteric infection.
- •Patients with colon cancer or dysplasia
研究组 & 干预措施
IBD patients receiving FMT
IBD patients receiving biologically active human fecal material sourced from OpenBiome. The physician will administer 250 mL of the fecal suspension in aliquots of 50-60 mL, through the endoscope. The material will be delivered to the most proximal point of insertion.
干预措施: Biologically active human fecal material, OpenBiome (Drug)
结局指标
主要结局
Clinical improvement of IBD
时间窗: 4 weeks
In order to assess clinical improvement of IBD, patients will be scheduled for a 4 week post-FMT treatment clinic visit to assess patient symptoms.
次要结局
- Efficacy of FMT treatment(4 weeks)
研究者
Najwa Elnachef
Assistant Professor
University of California, San Francisco